Combining Elemene with TKIs for treating advanced lung cancer

Synergistic Real-World Study and Evidence-based Medicine Evaluation of Elemene Combined With Tyrosine Kinase Inhibitors（TKIs）in the Treatment of Advanced Non-small Cell Lung Cancer (NSCLC): Prospective Study

This study is testing if combining a new treatment called Elemene with existing lung cancer drugs can help people with advanced lung cancer caused by specific genetic changes feel better and live longer.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 744 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hangzhou Normal University (Academic / other)
• Drugs / interventions: Gefitinib, Erlotinib, Icotinib, Osimertinib, Almonertinib, Furmonertinib, chemotherapy, Afatinib
• Locations: 7 sites (Nantong, Jiangsu and 6 other locations)
• Trial ID: NCT04401059 on ClinicalTrials.gov

What this trial studies

This nationwide, multicenter prospective cohort study aims to evaluate the synergistic effect and safety of combining Elemene with first or third generation EGFR-TKIs in patients with EGFR-mutated advanced non-small cell lung adenocarcinoma. The study will enroll approximately 744 patients who will be randomly assigned to either the experimental group receiving the combination treatment or the control group receiving TKIs alone. The research will also analyze the correlation between molecular biomarkers and patient prognosis, focusing on drug-resistant genes and circulating tumor cells. This approach seeks to address the challenge of acquired resistance to EGFR-TKIs, which affects many patients after initial treatment success.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced non-small cell lung adenocarcinoma and specific EGFR mutations.

Not a fit: Patients who have previously received Elemene or similar Chinese patent medicines within the last month may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that enhances the effectiveness of existing therapies for patients with advanced lung cancer.

How similar studies have performed: While there have been studies exploring the use of TKIs in EGFR-mutated lung cancer, the combination with Elemene represents a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18.
2. Histologically or cytologically confirmed advanced non-small cell lung adenocarcinoma(stage IIIB\~IV).
3. Patients with EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene), plan to receive First-generation EGFR-TKIs (Gefitinib, Erlotinib, Icotinib) or third generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib) monotherapy for the first time (patients who have been using first- or third-generation EGFR-TKIs for less than 28 days can be enrolled).
4. Patients positive for EGFR gene mutation (deletions in exon 19 and L858R in exon 21 of the EGFR gene), with disease progression after receiving chemotherapy can be enrolled.
5. Confirmed by investigators, tumor tissue can't be surgically excised.
6. No prior exposure to elemene injectable and/or oral emulsion within one month.
7. Prior exposure to other Chinese patent medicine with similar efficacy within one month. If more than one month, patients can be enrolled after a 30-day washout period (without continuing to use the above medications).
8. The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.

Exclusion Criteria:

1. Patients with any EGFR mutations other than 19DEL or 21L858R.
2. Accompanied by other active tumors. (Except for stable basal cell carcinoma after treatment， If metachronous tumors have been controlled, participating was allowed )
3. Exposure to First- or third-generation EGFR-TKIs combined treatment, for example, chemotherapy, anti-angiogenesis therapy.
4. Receiving radiotherapy or chemotherapy.
5. Pregnant or lactating women.
6. Allergic to Elemene.
7. Participating in other drug clinical trials.
8. Refuse to comply with the follow-up.
9. The researchers did not consider it appropriate to participate in this study for other reasons.

Where this trial is running

Nantong, Jiangsu and 6 other locations

• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
• Panjin Central Hospital — Panjin, Liaoning, China (Recruiting)
• Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai, China (Recruiting)
• The Second People's Hospital of Yangcheng County — Jincheng, Shanxi, China (Recruiting)
• Sichuan Academy of Medical Sciences· Sichuan Province People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Hangzhou Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Peking University Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Ziping Wang, PhD — Peking University Cancer Hospital & Institute
• Study coordinator: Tian Xie, PhD

Conditions Carcinoma; Non-Small-Cell Lung Cancer; Adenocarcinoma; Elemene; TKI; EGFR; Real-world study